Newsroom | 2164 results

Sorted by: Latest

Start-Up
-

內視鏡AI: AI Medical Service Inc.的胃部AI內視鏡診斷支援系統獲得泰國FDA監管核准

東京--(BUSINESS WIRE)--(美國商業資訊)-- 專注於內視鏡AI診斷技術研發的醫療初創企業AI MEDICAL SERVICE INC.(以下簡稱「AIM」)欣然宣布,已於2025年6月26日獲得泰國食品藥物管理局(泰國FDA)的醫療器材核准。此次獲准的是該公司的內視鏡影像診斷支援軟體「gastroAI-model G」。該系統利用人工智慧技術,輔助醫生在內視鏡影像中區分腫瘤性與非腫瘤性胃部病變。這代表泰國第一個具備病變區分1能力的上消化道AI診斷支援系統獲得監管核准2。 我們在泰國完成監管審查與器材註冊工作的背景情況 胃癌是全球第五大常見癌症,每年新增病例超過100萬,死亡人數約60萬3。胃癌的特點是,其死亡率會隨著病情的進展而顯著上升。然而,胃癌若能在早期被發現,往往是可以治療的;第一期胃癌病患的5年相對生存率約為95%,而第三期及以後病患的生存率不足50%4。儘管如此,早期胃癌難以檢測,據統計,其漏診率高達4.5%至25.8%5。 在泰國,胃癌死亡率居高不下(約75%6的確診病患死於該疾病),這顯示許多病例在確診時已處於晚期。這一醫療挑戰還因顯著的人口結構趨勢而加...
-

内窥镜AI: AI Medical Service Inc.基于AI的胃部内窥镜诊断支持系统获得泰国FDA监管批准

东京--(BUSINESS WIRE)--(美国商业资讯)-- 专注于内窥镜AI诊断技术研发的医疗初创企业AI MEDICAL SERVICE INC.(以下简称“AIM”)欣然宣布,已于2025年6月26日获得泰国食品药品管理局(泰国FDA)的医疗器械批准。此次获批的是该公司的内窥镜影像诊断支持软件“gastroAI-model G”。该系统利用人工智能技术,辅助医生在内窥镜影像中区分肿瘤性与非肿瘤性胃部病变。这标志着泰国首个具备病变区分1能力的上消化道AI诊断支持系统获得监管批准2。 我们在泰国完成监管审查与器械注册工作的背景情况 胃癌是全球第五大常见癌症,每年新增病例超过100万,死亡人数约60万3。胃癌的特点是,其死亡率会随着病情的进展而显著上升。然而,胃癌若能在早期被发现,往往是可以治疗的;Ⅰ期胃癌患者的5年相对生存率约为95%,而Ⅲ期及以后患者的生存率不足50%4。尽管如此,早期胃癌难以检测,据统计,其漏诊率高达4.5%至25.85。 在泰国,胃癌死亡率居高不下(约75%6的确诊患者死于该疾病),这表明许多病例在确诊时已处于晚期。这一医疗挑战还因显著的人口结构趋势而加剧:作...
-

Venova Technologies Awarded $2.23M SBIR Phase II Grant From NIH For Novel Contraceptive Device

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Venova Technologies, Inc., a women-led startup developing a novel long-acting, hormone-free and copper-free female birth control device, has been awarded a $2.23M Small Business Innovation Research (SBIR) Phase II Grant from the National Institutes of Health (NIH). The SBIR program is a highly competitive, awards-based program designed to stimulate technological innovations developed by U.S. small businesses on a path to commercialization. This Phase II award...
-

Endoscopic AI: AI Medical Service Inc. Has Obtained Regulatory Approval from Thailand’s FDA for Its Gastric AI-based Endoscopic Diagnosis Support System

TOKYO--(BUSINESS WIRE)--AI MEDICAL SERVICE INC. (hereinafter AIM), a medical start-up specializing in the development of diagnostic endoscopic AI, is excited to announce that it has received medical device approval from the Thai Food and Drug Administration (Thai FDA) on June 26, 2025. The approval is for its endoscopic image diagnosis support software, the "gastroAI-model G." This system utilizes artificial intelligence to assist physicians in differentiating between neoplastic and non-neoplas...
-

AIメディカルサービス:【内視鏡AI】タイにおける胃がん診断支援AIの認可を取得

東京--(BUSINESS WIRE)--(ビジネスワイヤ) -- 内視鏡の画像診断支援AI(人工知能)を開発する株式会社AIメディカルサービス(本社:東京都豊島区、代表取締役 多田 智裕、瀧川 泰司、以下「AIM」)は、2025年6月26日にAIを活用した胃病変の腫瘍性・非腫瘍性を判定する内視鏡画像診断支援システム(販売名:Endoscopic image diagnosis support software - gastroAI-model G)について、タイ保健省食品医薬品局(Thai Food and Drug Administration、以下「タイFDA」)から医療機器として認可されたことをご報告します。なお、タイにおける鑑別1機能を備えた上部消化管領域の診断支援AIの認可取得事例として初2となります。 ■タイにおける薬事認証取得を目指した背景 胃がんは世界で年間約100万人が罹患し、死亡者数は約60万人で、がん死亡者数の第5位に位置しています3。胃がんは早期に発見すれば十分に治療可能な疾患である一方、ステージが進行するにつれて生存率が大きく下がることが特徴で、5年相対生...
-

Bureau Veritas Expands its Footprint in New Strongholds Through Acquisitions in Cybersecurity, Nuclear and Transition Services

PARIS--(BUSINESS WIRE)--Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), announces three targeted acquisitions in the fast-growing sectors of Cybersecurity, Nuclear, and Transition Services as the company creates new portfolio strongholds. Bureau Veritas has signed an agreement with Dornier Group to acquire its Dornier Hinneburg subsidiary in Germany to strengthen its nuclear industry capabilities. It also signed agreements to acquire Institute For Cyber...
-

Bureau Veritas renforce sa présence dans de nouveaux bastions grâce à des acquisitions dans les domaines de la Cybersécurité, du Nucléaire et des Services de Transition

PARIS--(BUSINESS WIRE)--Bureau Veritas, leader mondial des services de test, d'inspection et de certification (TIC), annonce trois acquisitions ciblées dans les secteurs à forte croissance de la Cybersécurité, du Nucléaire et des Services de Transition, créant de nouveaux pôles stratégiques. Bureau Veritas a signé un accord avec le Groupe Dornier pour acquérir sa filiale Dornier Hinneburg en Allemagne afin de renforcer ses capacités dans l'industrie nucléaire. Il a également signé des accords p...
-

MACH Alliance Announces BILDIT as Winner of Inaugural FutureMACH Pitch Day Event

NEW YORK--(BUSINESS WIRE)--The MACH Alliance, a not-for-profit industry body dedicated to advancing composable enterprise architecture, has revealed the winner of its inaugural North American FutureMACH Pitch Day event. The winner, BILDIT, will gain access to exclusive mentorship, brand development and introductions to potential investors, fostering growth and innovation within the MACH ecosystem. Created by the MACH Alliance to support innovative MACH-aligned startup companies into their next...
-

Alloy Therapeutics and Kansai Startup Academia Coalition (KSAC) Announce Strategic Collaboration to Accelerate Global Growth of Japanese Life Science Startups

BOSTON & TOKYO--(BUSINESS WIRE)--Alloy Therapeutics Co. Ltd. (“Alloy Japan”) today announced the signing of a Memorandum of Understanding (MOU) with the Kansai Startup Academia Coalition (“KSAC”), represented by Kyoto University, to foster the global expansion of university-affiliated life science startups across Japan. This strategic collaboration is designed to accelerate research and development (R&D) activities by providing critical support and connecting academic innovations with the g...
-

Standard Chartered and Village Capital Celebrate Startups of Inaugural Women in Tech Accelerator

WASHINGTON, D.C. & NEW YORK--(BUSINESS WIRE)--Village Capital, in collaboration with Standard Chartered US, announced that Giving Credit and Imera were selected by their peers to receive USD 25,000 in grants to support their operations as part of the US Women in Tech Accelerator program. The initiative brought together a dynamic cohort of ten women-founded startups developing solutions to advance economic mobility and equitable access to essential services for women, families, and historically...